ARCHITECT 07K7810

GUDID 00380740014940

ARCHITECT Total Beta hCG Controls

ABBOTT IRELAND

Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control

Primary Device ID	00380740014940
NIH Device Record Key	28798b94-fb7a-46d0-a143-16af12c569b1
Commercial Distribution Status	In Commercial Distribution
Brand Name	ARCHITECT
Version Model Number	7K78-10
Catalog Number	07K7810
Company DUNS	989964119
Company Name	ABBOTT IRELAND
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx
Phone	+1(877)422-2688
Email	xx@xx.xx

Operating and Storage Conditions

Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00380740014940 [Primary]

FDA Product Code

DHA	SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-03-29
Device Publish Date	2016-09-09

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00380740129453	ARCHITECT Total T4 Calibrators
00380740119812	ARCHITECT Free T4 Reagent Kit (500T)
00380740119805	ARCHITECT Free T4 Reagent Kit (2000T)
00380740119799	ARCHITECT Free T4 Reagent Kit (100T)
00380740117818	ARCHITECT 25-OH Vitamin D Reagent Kit (2000T)
00380740116446	ARCHITECT 25-OH Vitamin D Reagent Kit (500T)
00380740116439	ARCHITECT 25-OH Vitamin D Reagent Kit (100T)
00380740106065	ARCHITECT ESTRADIOL REAGENT KIT 1 x 500
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00380740105983	ARCHITECT FSH Reagent Kit (500T)
00380740105976	ARCHITECT Ferritin Reagent Kit (500T)
00380740105969	ARCHITECT TSH Reagent Kit (500T)
00380740105952	ARCHITECT Total T4 Reagent Kit (500T)
00380740105945	ARCHITECT Total T3 Reagent Kit (500T)
00380740105938	ARCHITECT Free T4 Reagent Kit (500T)
00380740105921	ARCHITECT Free T3 Reagent Kit (500T)
00380740081126	ARCHITECT Free T4 Reagent Kit (100T)
00380740081065	ARCHITECT Free T4 Reagent Kit (2000T)
00380740081034	ARCHITECT Free T4 Calibrators
00380740014971	ARCHITECT Total Beta hCG Reagent Kit (2000T)
00380740014964	ARCHITECT Total Beta hCG Reagent Kit (100T)
00380740014940	ARCHITECT Total Beta hCG Controls
00380740014933	ARCHITECT Total Beta hCG Calibrators
00380740014926	ARCHITECT Progesterone Manual Diluent
00380740014919	ARCHITECT Progesterone Reagent Kit (100T)
00380740014896	ARCHITECT Progesterone Controls
00380740014889	ARCHITECT Progesterone Calibrators
00380740014865	ARCHITECT Prolactin Reagent Kit (100T)
00380740014841	ARCHITECT Prolactin Controls
00380740014834	ARCHITECT Prolactin Calibrators
00380740014810	ARCHITECT FSH Reagent Kit (100T)
00380740014797	ARCHITECT FSH Controls
00380740014780	ARCHITECT FSH Calibrators
00380740014728	ARCHITECT Estradiol Manual Diluent
00380740014711	ARCHITECT Estradiol Reagent Kit (100T)
00380740014698	ARCHITECT Estradiol Controls
00380740014681	ARCHITECT Estradiol Calibrators
00380740014445	ARCHITECT Total T4 Reagent Kit (2000T)
00380740014438	ARCHITECT Total T4 Reagent Kit (100T)
00380740014414	ARCHITECT Total T4 Controls
00380740014407	ARCHITECT Total T4 Calibrators
00380740014360	ARCHITECT Free T4 Controls
00380740014346	ARCHITECT Total T3 Manual Diluent

Trademark Results [ARCHITECT]

Mark Image Registration \| Serial	Company Trademark Application Date
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ARCHITECT 88875023 not registered Live/Pending	PREMIUM OUTDOOR PRODUCTS, LTD. 2020-04-16
ARCHITECT 88797756 not registered Live/Pending	DQC International Corp. 2020-02-14
ARCHITECT 88628662 not registered Live/Pending	Bowden Tactical LLC 2019-09-24
ARCHITECT 87650723 not registered Dead/Abandoned	AFM, LLC 2017-10-18
ARCHITECT 85971577 4527055 Live/Registered	Harbor MedTech, Inc. 2013-06-27
ARCHITECT 85733527 not registered Dead/Abandoned	Bristol-Myers Squibb Company 2012-09-20
ARCHITECT 85644736 4419447 Live/Registered	ALTISOURCE SOLUTIONS S.Ã R.L. 2012-06-06